Vitrakvi

Larotrectinib

• Brand(s): Vitrakvi
• Dosage Form/Strength: 25 mg, 100 mg capsules, 20 mg/mL oral liquid
• Effective date: February 24, 2023

For the treatment of unresectable locally advanced, or metastatic solid tumours in patients meeting ALL the following criteria:

1. Tumour is documented to have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; AND

2. Has failed all standard treatment for their tumour site; AND

3. Is not a candidate for surgery and/or radiation as it may lead to substantial morbidity; AND

4. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 for adults or 0 to 3 for children (less than 18 years old); AND

5. Larotrectinib is used as monotherapy.

Notes:

1. The patient’s NTRK gene fusion report must be submitted with the application.
2. The patient’s baseline radiographic evaluation (i.e., CT and/or MRI) should be provided on the initial funding application to EAP.
3. Patients with symptomatic brain metastases, unstable cardiovascular disease, or on treatments that are strong CYP3A4 inhibitors or inducers should be carefully considered and monitored.

Renewal Criteria:
Renewals will be considered in patients who have not experienced disease progression or unacceptable toxicities requiring discontinuation while on Larotrectinib.
Please provide radiographic and/or scan results indicating no progression with requests for renewal of funding.
Evaluation according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1 criteria and Response Assessment in Neuro-Oncology for CNS tumours.

Recommended dose:
• 100 mg orally twice daily in patients with Body Surface area (BSA) greater than or equal to 1 m²
• 100 mg/m² orally twice daily for children (less than 18 years old) with BSA less than 1 m².

Approval duration of initials: 3 months

Approval duration of first renewal: 3 months

Approval duration of 2nd renewal: 6 months

Approval duration of 3rd and subsequent renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests